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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DC020194 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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There is a rapidly growing population of adult and pediatric cochlear implant (CI) recipients with acoustic hearing preservation in the implanted ear(s) allowing for combined Electric and binaural Acoustic Stimulation (EAS). Despite the rapid technological and surgical advancements that have led to this increased prevalence, there is limited research on EAS outcomes-particularly for pediatric EAS listeners-including the expected trajectory of benefit following EAS fitting and underlying mechanisms driving benefit in EAS users of all ages. Thus, the purpose of this project is to provide a comprehensive description of behavioral and electrophysiologic measures of binaural hearing in adults and children both with normal hearing and EAS users.
Cochlear implantation with minimally traumatic surgical techniques and atraumatic electrode arrays has led to an increasing prevalence of adult and pediatric cochlear implant (CI) recipients with the potential for combined Electric and binaural Acoustic Stimulation (EAS). Many studies have demonstrated that adult EAS users consistently exhibit significant benefits for speech understanding in noise and spatial hearing tasks as compared to a CI paired only with a contralateral HA. We have also demonstrated that sensitivity to interaural time difference (ITD) and interaural level difference (ILD) cues is correlated with EAS benefit for postlingually deafened adult listeners. Despite this active phase of discovery, there is still a striking paucity of research on EAS outcomes in pediatric CI users, the expected trajectory of benefit following EAS fitting, as well as underlying mechanisms driving EAS benefit (or lack thereof) in all populations. There is a disconnect between EAS availability and EAS utilization in all CI recipients and current audiological management of EAS candidates is not data driven. This is problematic given the protracted maturation of the binaural system and the fact that we do not understand what additional effects sensorineural hearing loss and combined EAS may have on the developing binaural system. The proposed research activities will describe the time course of binaural development using behavioral and objective responses to interaural differences in timing (phase) and level as well as allow for a natural factor investigation of a clinical intervention, the EAS fitting, on said development. Within the context of a clinical trial, we will compare acute and chronic EAS outcomes for speech recognition and spatial hearing as related to binaural cue sensitivity, cue weighting, and underlying neural synchrony necessary for ITD resolution. We have proposed a single-group assignment for both adult and pediatric EAS users and will also include chronological- and hearing-age-matched listeners with normal hearing (NH). A within-subjects, accelerated longitudinal design for both EAS and NH listeners will provide insight into the developmental trajectory of the binaural system for children NH and will provide a benchmark for interpreting effects of sensorineural hearing loss, asymmetry in audibility resulting from cochlear implantation, and EAS use on said trajectory. Our proposed research activities will help close the gap between what is technologically possible with EAS technology and what is clinically implemented by otologists and audiologists investigating development of binaural sensitivity and spatial hearing abilities. The resultant data will comprise the first comprehensive description of behavioral and electrophysiologic measures of binaural hearing in adults and children both with NH and EAS and will uncover information about our EAS clinical populations holding high potential for clinical application in device fittings as well as audiologic and otologic clinical recommendations regarding cochlear implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with normal hearing |
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| Adults with normal hearing |
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| Children with bilateral steeply sloping sensorineural hearing loss |
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| Adults with bilateral steeply sloping sensorineural hearing loss |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| binaural processing over time | Behavioral | This study will not provide an intervention, but will study the effects of hearing technology on binaural processing for adults and children with bilateral steeply sloping sensorineural hearing loss |
| Measure | Description | Time Frame |
|---|---|---|
| EAS benefit for speech recognition in noise and spatial hearing abilities | For children and adults who are pursuing cochlear implantation with acoustic hearing preservation, we will describe the rate of hearing preservation following implantation. This is critical as it is well-known that individuals with acoustic hearing preservation achieve significantly higher scores on tasks of speech recognition in noise, particularly with diffuse noise. | 2 years |
| Binaural cue sensitivity (interaural time and level differences) | For children and adults with precipitously sloping, high-frequency sensorineural hearing loss pursuing cochlear implantation, we will describe binaural cue sensitivity pre- and post-implant. | 2 years |
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Inclusion Criteria:
Pediatric EAS: aged 5-17; Adult EAS: aged 18+ years
At least one CI and bilateral mild to profound sensorineural hearing loss with unaided audiometric thresholds ≤ 80 dB HL at 125 and 250 Hz, in both ears.
For children and adults with normal hearing, they will demonstrate audiometric thresholds 20 dB HL or better from 250-8000 Hz
Exclusion Criteria:
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Individuals with steeply sloping sensorineural hearing loss in both ears
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rene H Gifford, PhD | Contact | 405-548-4300 | rene.gifford@heartsforhearing.org | |
| Sara Neumann, AuD | Contact | 405-548-4300 | sara.neumann@heartsforhearing.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hearts for Hearing | Recruiting | Oklahoma City | Oklahoma | 73120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23446225 | Background | Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163. | |
| 28301392 | Background | Gifford RH, Davis TJ, Sunderhaus LW, Menapace C, Buck B, Crosson J, O'Neill L, Beiter A, Segel P. Combined Electric and Acoustic Stimulation With Hearing Preservation: Effect of Cochlear Implant Low-Frequency Cutoff on Speech Understanding and Perceived Listening Difficulty. Ear Hear. 2017 Sep/Oct;38(5):539-553. doi: 10.1097/AUD.0000000000000418. |
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Once the study is complete, we will make the fully de-identified data set available to investigators upon request.
November 30, 2028 is the anticipated date the de-identified IPD will be available. There is no end date determined as of yet.
Interested investigators may reach out to the study PI (Rene Gifford, PhD) at rene.gifford@heartsforhearing.org to inquire about obtaining de-identified IPD starting November 30, 2028.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Pediatric study participants | Apr 15, 2025 |
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| binaural processing over time for children and adults with normal hearing | Behavioral | Adults and children with normal hearing will be studied over time to characterize binaural processing and associated effects on speech perception in complex listening scenarios and spatial hearing abilities. |
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| 32182551 | Background | Gifford RH, Stecker GC. Binaural cue sensitivity in cochlear implant recipients with acoustic hearing preservation. Hear Res. 2020 May;390:107929. doi: 10.1016/j.heares.2020.107929. Epub 2020 Feb 26. |
| 33555745 | Background | Holder JT, Morrel W, Rivas A, Labadie RF, Gifford RH. Cochlear Implantation and Electric Acoustic Stimulation in Children With TMPRSS3 Genetic Mutation. Otol Neurotol. 2021 Mar 1;42(3):396-401. doi: 10.1097/MAO.0000000000002943. |
| 33859136 | Background | Roberts JB, Stecker GC, Holder JT, Gifford RH. Combined Electric and Acoustic Stimulation (EAS) in Children: Investigating Benefit Afforded by Bilateral Versus Unilateral Acoustic Hearing. Otol Neurotol. 2021 Aug 1;42(7):e836-e843. doi: 10.1097/MAO.0000000000003139. |
| 35985964 | Background | Gifford RH, Sunderhaus LW, Dawant BM, Labadie RF, Noble JH. Cochlear implant spectral bandwidth for optimizing electric and acoustic stimulation (EAS). Hear Res. 2022 Dec;426:108584. doi: 10.1016/j.heares.2022.108584. Epub 2022 Jul 28. |
| 39514431 | Background | Reinhart P, Parkinson A, Gifford RH. Hybrid Cochlear Implant Outcomes and Improving Outcomes With Electric-Acoustic Stimulation. Otol Neurotol. 2024 Dec 1;45(10):e749-e755. doi: 10.1097/MAO.0000000000004305. |
| 38763034 | Result | Fan Y, Gifford RH. Objective measure of binaural processing: Acoustic change complex in response to interaural phase differences. Hear Res. 2024 Jul;448:109020. doi: 10.1016/j.heares.2024.109020. Epub 2024 Apr 28. |
| Jul 16, 2025 |
| ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Adult participants | Apr 15, 2025 | Jul 16, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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